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Personal Injury Lawyer News and Updates from Personal Injury Attorneys.
Special reports on Chicago Personal Injury news
FDA Issues "Clinical Hold" on Controversial Avandia Study
1 Aug 2010 at 11:47pm
Posted by
questions@pintas.com (William G. Pintas)
As uncertainty surrounds the safety of the popular diabetes drug Avandia, federal health officials are prohibiting new patients from enrolling in a safety study of the prescription medication because of the associated risks. The TIDE study is designed to give a definite answer to whether or not Avandia holds more risk for heart problems than similar drugs. The Federal Food and Drug Administration (FDA) issued a “partial clinical hold” on the TIDE trial, which Avandia’s manufacturer GlaxoSmithKline agreed to conduct when the drug’s safety was first questioned in 2007. However, patients who are already participating are permitted to continue.
A panel of experts recently voted that although Avandia seems to increase the risk of heart problems, the majority voted to leave it on the market. Some health professionals are arguing that the TIDE trial is unethical since there is enough evidence to prove that the drug is more dangerous. Other health professionals have speculated that Avandia will be pulled off the market soon.
ACLU Claims Illinois Nursing Homes Use Scare Tactics to Keep Patients
31 Jul 2010 at 4:22pm
Posted by
questions@pintas.com (William G. Pintas)
The State of Illinois recently reached a court settlement that offers supportive community-based housing and treatment to about 4,500 psychiatric patients who currently reside in nursing homes. Following this settlement, the Chicago Tribune reported that the American Civil Liberties Union (ACLU) filed court papers stating that Illinois for-profit nursing home operators were using scare tactics to keep psychiatric patients in their facilities, instead of letting them move into supporting community-based housing. Nursing Home operators deny these allegations and raise concerns about whether the State can provide appropriate housing for such patients.
The current argument between the ACLU and Nursing Home operators stems from the latter’s distribution of “information sheets” which, according to the ACLU, state that the court settlement purposefully lacks details” and may take away protections for people who do leave the nursing home. Specifically, the information sheets state that the settlement does not specify “where you’ll move, how you’ll pay rent, how you’ll be fed, who will help you with your medication and other medical needs, or what happens if you don’t like it and want to return [to the nursing home]”. Nursing Home operators state the “information sheets” are accurate, and that they are worried the State will not deliver on its promise to care for the psychiatric patients that move into the new community settings.
State officials responded that psychiatric patients are free to choose where they want to go, and that nursing home operators are wrong to deny that the smaller community settings may be less expensive and more therapeutic.
FDA Panelist Defending Avandia was on its Manufacturer's Payroll
23 Jul 2010 at 11:23pm
Posted by
questions@pintas.com (William G. Pintas)
It was recently reported by the Wall Street Journal that one of the members of the government advisory panel who voted to back Avandia last week was on GlaxoSmithKline’s payroll. More specifically, endocrinologist David Capuzzi is a paid speaker for the drug manufacturer.
Avandia, a diabetes drug, has carried the Federal Food and Drug Administration’s (“FDA’s”) strongest warning, a black box warning, regarding its risk for heart problems since 2007. Last week, a FDA advisory panel met to consider further restrictions on the drug in the wake of new information indicating it to be more harmful than previously thought. During the meeting of 33 panel members, 12 voted Avandia should be withdrawn; 10 voted its sales should be restricted and warning labels enhanced; 7 voted solely for enhanced warning labels; and 3 voted to keep Avandia on the market with no changes to its warnings. Because of the lack of unity, it is difficult to predict what the FDA will do with regard to the drug.
According to the Wall Street Journal, Dr. Capuzzi was one of the three panel members who voted to keep Avandia on the market with no changes to its warnings, and defended the drug during the two-day panel meeting. Dr. Capuzzi has received almost $15,000 in speaking fees from GlaxoSmithKline, but has denied previously speaking about Avandia. The controversy surrounding Dr. Capuzzi and Avandia highlights a problem in the FDA’s regulations: the disclosure form for outside experts who advise the FDA on risky drugs only requires them to list fees from speaking or writing for a drug company for the previous 12 months or that are under negotiation. This is typically too short a period of time to catch most conflicts in the pharmaceuticals business. In Dr. Capuzzi’s case, the FDA’s current requirement would not have captured the majority of GlaxoSmithKline’s payments to him.
New Report Says Over-the-Counter Nasal Gels are Ineffective and May Cause Los...
22 Jul 2010 at 9:56pm
Posted by
questions@pintas.com (William G. Pintas)
Popular over-the-counter nasal gels may cause loss of smell or anosmia. Over-the-counter nasal gels, such as Zicam, are generally used to treat common cold symptoms. Patients use this product by wiping the gel inside the nasal passages. Doctors state it is likely the nasals gels cause loss of smell because they contain zinc gluconate. They also express doubt that the products are actually effective at treating common cold symptoms, stating “Multiple trials have found that intranasal zinc is ineffective in preventing or reducing the duration of the common cold.”
Some doctors said that products containing zinc gluconate do nothing to treat the common cold, and any relief experienced after usage is psychological. As Dr. Terence Davidson of the Nasal Dysfunction Clinic at the University of California, San Diego, School of Medicine says, “When the gel is inserted into the nose, it gives you a little bit of a burn, so it has a nice psychological feel to it. That’s why it’s ended up...
GlaxoSmithKline Hid Relevant Data on Avandia's Risk for Cardiovascular Problems
15 Jul 2010 at 10:08am
Posted by
questions@pintas.com (William G. Pintas)
As a follow-up to our previous blog on the current controversy surrounding the popular diabetes drug Avandia, it was recently reported that Avandia’s manufacturer GlaxoSmithCline hid a 1999 study that indicated the drug’s danger.
In the fall of 1999, the manufacturer secretly began a study to test if Avandia was better and safer in terms of heart problem risks than the competing drug Actos. The study showed that Avandia was not better than Actos, and was in fact riskier for the heart. The company did not share these results, but instead tried to cover them up, likely due to fear of lost profits. In most cases, the law requires posting the results in a public forum or submitting them to federal drug regulators. In fact, GlaxoSmithKline has not only hid valuable data regarding Avandia’s safety, it has also manipulated data to make the drug appear less risky.
Avandia went on to become one of the most popular drugs in the world, earning GlaxoSmithKline hundreds of millions in profits....
FDA Withdraws Cancer Drug Due to Lack of Benefit and Increased Deaths
13 Jul 2010 at 10:57pm
Posted by
questions@pintas.com (William G. Pintas)
Recently, Pfizer Inc voluntarily withdrew the drug Mylotarg (gemtuzumab ozogamicin) from the U.S. market. Mylotarg is used to treat patients with acute myeloid leukemia, a bone marrow cancer. Pfizer withdrew the drug at the request of the Federal Food and Drug Administration (FDA) since a new clinical trial yielded both new safety concerns and lack of benefit to patients.
Mylotarg was approved by the FDA in 2000 to treat patients 60 years or older who had recurring acute myeloid leukemiaand were not candidates for chemotherapy. The drug originally obtained “accelerated approval”, which allows the FDA to approve drugs for serious illnesses with little alternative treatment options. based on solely a laboratory measurement or physical sign. The laboratory measurement or physical sign are used in place of a clinical trial which directly measures the drug’s effect on a patient’s health. Usually drugs with accelerated approval are required to conduct clinical trials after approval to pr...
Experts Debate if Avandia Clinical Trial is Ethical
12 Jul 2010 at 11:20am
Posted by
questions@pintas.com (William G. Pintas)
Over the past couple of years, the safety of the popular diabetes drug Avandia has been the source of much debate, due to claims that it increases the risk of heart attack. Recently, it was reported that a clinical trial conducted by Avandia is being increasingly scrutinized by experts.
Some specialists and FDA officials stated that Avandia is too dangerous to stay on the market due to its risks. As a result, they also contend that the current Avandia trial is unethical, and subjects patients to the increased risk of heart problems. However other experts, as well as manufacturer GlaxoSmithKline, have stated that the drug is not harmful and the clinical trial is essential to providing some definite answers about Avandia’s risks.
The current controversy surrounding Avandia highlights the difficulties the FDA encounters in protecting consumers when a highly popular and profitable drug is shown to be unsafe. In addition, the problems surrounding Avandia also trigger new questions ove...
Illinois Nursing Home Gets License Revoked
7 Jul 2010 at 10:18am
Posted by
questions@pintas.com (William G. Pintas)
Recently, the Chicago Tribune reported that Illinois health authorities have moved to revoke the license of Evergreen Health Care Center in Evergreen Park, a southwest suburban nursing home. Evergreen Health Care is partly owned by state Senator Heather Steans, a prominent advocate of reform legislation to improve safety and care standards in Illinois nursing homes. The revocation of its license follows from repeated citations for patient neglect.
Evergreen Health Care was recently added to a federal watch list for nation's most troubled nursing homes. Previous inspections there yielded several safety breaches, such as failure to prevent maggots from infecting the scalp wound of an elderly skin cancer victim. South Shore Nursing & Rehabilitation Center was also recently added to the federal watch list due to safety violations. There are currently five Illinois facilities on the federal watch list.
Contact an Experienced Nursing Home Injury Attorney
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American Signature Entertainment Centers Recalled Due to Hazard
24 Jun 2010 at 11:44pm
Posted by
questions@pintas.com (William G. Pintas)
Recently,the U.S. Consumer Product Safety Commission (CPSC) issued a recall of entertainment centers due to a fall hazard. About 24,000 units were recalled because the shelves of the entertainment centers can detach and fall when moved. The following modes were part of the recall:
· Arts and Crafts
· Vineyard Manor
· Lake Cottage
· Studio One
· West Indies
· Plantation Cove
The units are sold at Value City Furniture, Rooms Today and American Signature Furniture stores. So far, the CPSC has received four reports of the shelf collapsing, with two reports of serious injuries. Consumers with the recalled product should contact American Signature Inc. for a free repair kit. Click here to read the CPSC press release regarding the recall.
Serious Denture Cream Risks
23 Jun 2010 at 11:26am
Posted by
questions@pintas.com (William G. Pintas)
Consumers who are currently using denture creams containing zinc may not realize the great risks associated with their usage. Two of the most popular denture creams on the market, Super Poligrip (manufactured by GlaxoSmithKline) and Fixodent (manufactured by Procter & Gamble) have been linked to the development of serious illnesses such as copper depletion that may result in neurological problems (or nerve damage).
Denture creams have been on the market for several years, and is considered a Class I medical device by the Federal Food and Drug Administration, meaning it does not require a warning label. However, in 2008, a study published in the medical journal Neurology found that long-term use of denture cream could lead to patients developing neurological problems due to having too little copper in their blood. The denture cream contains zinc, and too much zinc in one’s diet can lead to depletion of copper in the blood, which affects the spinal cord and causes subsequent nerve...
Popular Blood Pressure Medications May Lead to Higher Risk of Cancer
19 Jun 2010 at 12:54am
Posted by
questions@pintas.com (William G. Pintas)
New research recently published in the medical journal, Lancet Oncology, reports that some of the most popular blood pressure pills, such as Micardis, could increase a patient’s risk of cancer. After analyzing five previous studies, scientists found that taking medications known as angiotensin-receptor blockers (ARBs) lead to an increase in cancer. ARBs are typically taken for conditions such as high blood pressure, heart problems and kidney disease from diabetes.
The increase in cancer risk applies to many different types of cancers, including prostate, breast and lung cancer. Some doctors are starting to think twice about prescribing ARBs due to this newfound risk. However, they also state that in some cases the benefits of taking ARBs may outweigh the risks. Because cancer can take years to develop, it is difficult to know if a new drug will hold a cancer risk until after it has been on the market for an extended period of time. At this time, some doctors have called on reg...
New Warning for Weight Loss Drugs Alli and Xenical
8 Jun 2010 at 6:22pm
Posted by
questions@pintas.com (William G. Pintas)
Alli and Xenical are both drugs used by consumers for weight loss. Xenical requires a prescription, while Alli is an over-the-counter version that contains lower doses. On June 24, 2009, the FDA listed both drugs under investigation for safety issues of liver toxicity. Alli has also been in the news for problems in counterfeits of the drug.
Recently, the FDA ordered label changes on these drugs. The warning is regarding the risk of severe liver damage as a result of using the drugs. Both drugs contain the active ingredient orlistat, which blocks absorption of fats in the intestines. So far, the FDA has reports of 13 cases of severe liver damage associated with usage of the drugs, with two cases resulting in death. Symptoms of liver damage include dark urine, loss of appetite, light-colored stools, and yellow coloring in the eye whites and skin.
Salmonella Outbreak at Subway Restaurant
7 Jun 2010 at 7:29pm
Posted by
questions@pintas.com (William G. Pintas)
The Chicago Tribune recently reported that health officials are investigating a salmonella outbreak in many Subway restaurants throughout Illinois . So far, 34 people have reported becoming ill with 14 requiring hospitalization. Symptoms of salmonella typically include fever, cramps and diarrhea.
Subway has voluntarily withdrawn suspected contaminated produce from its restaurants. Officials are advising anyone who has become sick after eating at an Illinois Subway on or after May 10, 2010 to contact their local health department. The following counties have reported patients becoming ill after eating in their Subway restaurants: Sangamon, Schuyler, Christian, Bureau, LaSalle, Cass, Champaign, Peoria, Shelby, Warren, Macon, Ogle, Fulton and Tazewell.
First Avandia Case Settled by GlaxoSmithKline
3 Jun 2010 at 7:05pm
Posted by
questions@pintas.com (William G. Pintas)
In February 2010, Avandia made headlines due to the uncovering of confidential government reports where doctors from the Federal Food and Drug Administration (FDA) concluded that “Rosiglitazone [Avandia] should be removed from the market.” Avandia is a popular drug used to treat Type 2 diabetes, and has been linked to a higher risk of heart attack and heart failure than any other diabetes drug
Recently, the Wall Street Journal reported that the first Avandia case brought to trial in the U.S. over the increased risks associated with the drug has settled. Details have not been given for the settlement yet, as the terms remain confidential. . GlaxoSmithKline, Avandia’s manufacturer, are schedule for another trial over Avandia in October 2010, and the multi-district Avandia litigation is still pending in federal court.
The FDA is also evaluating Avandia’s safety profile next month. It is possible that the drug will be pulled from the market due to its risks.
Tougher Warnings Placed on Painkillers Ultram and Ultracet
2 Jun 2010 at 6:54pm
Posted by
questions@pintas.com (William G. Pintas)
Recently, Johnson & Johnson strengthened suicide warnings for two of its painkillers: Ultram and Ultracet. The changes come in the wake of reports of suicide deaths of patients with medical histories of emotional problems and drug abuse. Both Ultram and Ultracet contain tramadol, an opioid, that is more potent when combined with alcohol, other painkillers, or drugs that depress the central nervous system.
Caution is particularly recommended for patients taking Ultram and Ultracet who are currently on tranquilizers, antidepressants or who consume excessive amounts of alcohol. Patients who are suicidal or have past histories of addiction problems should also use caution with the drug.
Click here to read the FDA’s warning letter to healthcare professionals about the drugs.
UV Nail Dryers May Be Linked to Skin Cancer
5 Aug 2010 at 11:29am
Posted by Jamie G. Goldstein
UV nail lights emit high doses of UV-A which a body of evidence links to skin cancer. A couple of cases have arisen where middle-aged women who regularly use the nail dryers have had non-melanoma skin cancers on their hands alone. Neither of the women had any family history of skin cancer.
Tanning salons are required to post warnings about the risks of UV rays, so why aren’t nail salons? UV light is used in nail salons for UV gel nails, acrylic nails, fill-ins, and regular nail polish. Many may be unaware of this risk. The UV radiation from nail lights is comparable to tanning beds. Dermatologists say even using the lights occasionally can amount to a lot of UV exposure. For those getting their next manicure or pedicure, the safest bet is probably to air dry those nails.
Originally posted at InjuryBoard by Jamie G. Goldstein
Over 1 in 100 Hospitalized Patients in U.S. Acquire Bacterial Infection
4 Aug 2010 at 5:00am
Posted by Jamie G. Goldstein
Clostridium difficile has now become the most common hospital acquired infection (HAI) in the United States. This bacteria can cause diarrhea and colon inflammation that could possibly be deadly.
The U.S. Center for Disease Control and Prevention to ask for state plans to combat this epidemic. One of the reasons this infection has become more prevalent is because hospitals have moved away from hand washing and more towards the use of alcohol-based hand washing solution which does not eliminate clostridium difficile. In order to disinfect against this bacteria hands must be washed with soap and water to eliminate the spores and patient’s rooms must be cleaned with bleach.
Although hand washing is more time consuming and costly than using alcohol solutions, it should still be practiced if more effective at preventing disease and saving lives. It’s important to remember that although convenient, hand sanitizer is not a replacement for good old fashioned soap and water. Hand washing...
Radiation Overexposure from Stroke Scans Causes Hair Loss, May Lead to Future...
3 Aug 2010 at 10:27am
Posted by Jamie G. Goldstein
Over 400 patients received overdoses of radiation at 8 hospitals in the United States while undergoing CT brain perfusion scans. CT perfusion scans are used to generate an image of the brain used to diagnose strokes. The problem was discovered after patients undergoing the scans had their hair unexpectedly fall out in a clearly defined ring pattern around their heads. After the scans, some patients said they felt sick and confused. The embarrassing new hair style was difficult to conceal and caused these patients needless emotional trauma and anxiety. Most seriously, experts say that long-term these patients could be at increased risk for brain damage, cancer, and possibly eye problems.
CT perfusion scans are loosely regulated. The scan requires a large dose of radiation, but there is no standard for how much is too much. Some patients received up to 8 times the recommended amount of radiation. The FDA began an investigation into the scans in 2009 but thus far has not made any co...
Is the Cure Worse Than the Disease? Avandia Now Also Linked to Broken Bones
2 Aug 2010 at 6:11am
Posted by Jamie G. Goldstein
Diabetes drugs in the thiazolidinediones family (TZDs) such as Actos and Avandia are now linked to a higher risk for bone fractures, a new study confirms. Avandia has been scrutinized this summer because of its possible dangers for heart health. This new risk calls for even more caution for those taking the drug, especially post-menopausal women. Post-menopausal women are already at a higher risk of fracture because of decreased bone density.
A recent study published in the Journal of Clinical Endocrinology & Metabolism showed that women who were over 50 and suffered fractures were 71% more likely to be taking either Avandia or Actos. Risk of fracture increased the more the drug was taken. Increased fracture risk was also linked to men taking Avandia or Actos, however mainly when combined with a “loop diuretic.”
Originally posted at InjuryBoard by Jamie G. Goldstein
Absolutely Stun-ning -- TASERS Reportedly Being Used in Hospitals
21 Jul 2010 at 12:43pm
Posted by Jamie G. Goldstein
A hospital security guard used a stun gun on Supreme Court Justice Clarence Thomas’ nephew, Derek Thomas, after he refused to wear a gown and attempted to leave the grounds of West Jefferson Hospital in Marrero, Louisiana, according to his family.
The incident has shed light on the fact that tasers and stun guns, weapons known for their use on rioters, criminals, and let’s not forget this guy, are now being used to subdue unruly patients in many hospitals.
The Washington Post now reports that Taser brand devices are being used or tested in 151 hospitals across the country. According to a Taser company spokesperson, tasers are an “effective response…to halt violent situations.” However, what effect could the electrical shocks have on a hospital patient who may be in an already debilitated physical condition?
Tasers work by shooting 50,000 volts of electricity through barbed hooks that stick into a target’s body. There have been a number of incidents of taser-related deaths. In 20...
Avandia UPDATE
15 Jul 2010 at 10:43am
Posted by Jamie G. Goldstein
The Avandia saga continues...
The FDA panel of experts has voted outside of Washington D.C. on whether or not to take Avandia off the market and the results are in. 12 members voted to eliminate Avandia sales distribution, 10 voted to improve warning labels on the drug and possible place restrictions on distribution, 7 voted for improved warning labels alone, and 3 voted for no change. The divided vote reflects the ongoing debate within the FDA on Avandia's safety.Originally posted at InjuryBoard by Jamie G. Goldstein
It?s Decision Time on Avandia
14 Jul 2010 at 12:39pm
Posted by Jamie G. Goldstein
A group of medical experts are meeting at an FDA panel this week to vote on whether or not the diabetes drug Avandia, which some studies show poses an increased risk of heart problems for some patients, should be taken off the market. GlaxoSmithKline claims that Avandia’s health risks have been taken out of context, but it has recently come to light that the drug manufacturer has known about the danger since 1999 when they conducted their own study against competitor drug Actos. Unsurprisingly, instead of disclosing the results the company chose to protect its bottom line. GlaxoSmithKlein points to its own RECORD study to insist that Avandia is safe. However documents also revealed that the study was poorly executed and possibly inaccurate. Some participants who experienced heart attacks were excluded from the trial’s final data outcome, skewing the results more favorably towards Avandia.
FDA scientist Dr. David Graham lambasted the RECORD study’s credibility, saying that basing a d...
Personal Plea: New Information on Dan Firkins Death, Still No One to Blame
27 May 2010 at 1:29pm
Posted by Jamie G. Goldstein
It has been almost two weeks since Dan Firkins' life was taken away from him. As more information begins to surface there are more unanswered questions. Danny was found with 2 skull fracture lying unconscious on the street near the corner of Honore and North Avenue in Chicago's Bucktown neighborhood. Witness say that he may have had a disagreement with a cab driver when the cab pulled away while Danny was partially inside the passenger side window of the cab. Questions are now being raised as to whether or not Danny was hit with some type of object before the cab pulled away.
With two skull fractures and the shape that Danny was found, it seems that there is definitely more to this story, and I would not be surprised if Danny was hit with an object. It seems something more would have had to have happened to give him such horrific injuries.
Whoever did this to Danny, intentionally left him barely clinging to life in the middle of the street. I do not understand how any descent human ...
Personal Plea: Death of Dan Firkins, Still Looking for Cab Driver Responsible
24 May 2010 at 6:18am
Posted by Jamie G. Goldstein
After suffering two skull fractures and other injuries, Danny Firkins life came to an end on Saturday May 22, 2010, just over a week after he had been run over by a Chicago cab driver who fled the scene. Danny was a bright 32 year old man with a great future ahead of him. He was taking classes at the University of Chicago's business school. He had a great family that he cared for deeply and was a friend to everyone, including myself. He lit up the room with his smile and humor. Just over a week ago, that was all taken away by the senseless act of another human being who has yet to be found.
A reward of $20,000 has been offered for information leading to the arrest and conviction of the person who killed Danny Firkins. It is believed he was ran over by a cab with a blue stripe being driven by a man of Middle Eastern descent. This was in the middle of the day, Friday May 14, 2010, at 3:30 in Bucktown near the corner of Honore and North on a Friday. Someone knows something and ...
Personal Plea: Please Help Find the Cab Driver that Left Dan Firkins Clinging...
21 May 2010 at 10:16am
Posted by Jamie G. Goldstein
On May 14, 2010, one of my best friends from college was dragged by a cab and left for dead in broad daylight. Danny Firkins was hailing a cab to go to class one week ago at about 3:30 in the afternoon near the corner of Honore and North Avenue in Bucktown. It is believed Danny and the cab driver were arguing and the cab pulled off while Danny was leaning into the passenger side of the cab. Danny's body was dragged a distance before he was run over by the cab and left for dead. An ambulance arrived at the scene and transported him to the hospital, but he had been deprived of oxygen while the paramedics were trying to save his life. Danny is now lying in a coma at the hospital. He is in critical condition.
A community alert was recently posted stating the cab has been described as white with teal blue stripes, as well as white with red stripes. The driver has been described as a male of Middle Eastern descent with a dark complexion and mustache.
Danny is a smart and talented...
 
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